Recall Z-1561-2013 ยท CAN Regulator, Pressure, Gas Cylinder
Linde Gas North America Llc
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx onl
| Date | Jun 20, 2013 (initiated Mar 8, 2013) |
| Status | Terminated |
| Reason | A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, The Linde Group, sent a "Voluntary Medical Device Recall" letter dated June 21, 2013 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to view the enlarged photo on the reverse side of the notice for guidance. If you or your customers have a Unit with lot number 25/07, then please return it with the Product to your local LifeGas fill center as soon as possible. No other lot numbers are subject to this removal action. Customers with questions should contact Linde's Customer Care Center at 1-866-LIFEGAS (543-3427). |
| Quantity | 52,264 units (1106 units) |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.